Veterinary Medicines Bioproducts India Private Limited Bangalore
Readiness for e-submissions Veterinary medicines agencies
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Readiness for e-submissions Veterinary medicines agencies Per Helboe
description
Readiness for e-submissions Veterinary medicines agencies. Per Helboe. Questionnaire to all NCA’s. Response from 15 NCA’s, incl. EMEA – 50% AT, BE, CY, DE (BVL), DE (PEI), DK, EE, EMEA, ES, FR, HU, LV, NL, SE, UK. Questionnaire – main questions. - PowerPoint PPT Presentation
Transcript of Readiness for e-submissions Veterinary medicines agencies
Readiness for e-submissionsVeterinary medicines agencies
Per Helboe
Readiness for e-submissions 2
Questionnaire to all NCA’s
• Response from 15 NCA’s, incl. EMEA – 50%
• AT, BE, CY, DE (BVL), DE (PEI), DK, EE, EMEA, ES, FR, HU, LV, NL, SE, UK
Readiness for e-submissions 3
Questionnaire – main questions
• Will the agency accept e-submissions without paper by January 2010
• Has the agency published national guidelines and given reference to EU guideline
• Number of applications per year – total and e-versions
• Method to ensure identity of applicant
Readiness for e-submissions 4
Readiness January 2010
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12
14
Nu
mb
er o
f co
un
trie
s
Ready 2010
Not Ready
Not known
Readiness for e-submissions 5
Published guidelines
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16
Nu
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Published
National
Reference to EU harmonised
Readiness for e-submissions 6
Total number of applications/e-submissions
0
200
400
600
800
1000
1200
AT BE CY DE/BVL DE/PEI DK EE EMEA ES FR HU LV NL SE UK
Total
e-Version
Readiness for e-submissions 7
Total number of applications/e-submissions
0
20
40
60
80
100
120
140
160
180
AT BE CY DE/BVL DE/PEI DK EE EMEA ES FR HU LV NL SE UK
Total
e-Version
Readiness for e-submissions 8
Identity of the applicant
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2
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10
12
14
Nu
mb
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of
cou
ntr
ies
Signed letter
Scanned signed letter
Digital signature
Other
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